#7-4. Regulatory limitations of the 3D printing technology and future goals

Dr. Jung-whan Baek (H Plastic Surgery)

Image 5-1. Achieve as close occlusion as possible and bring the condyles in the normal position. Predict the occlusal fit and reconstruct the defect.

Image 5-2. 3D modeling is used to fabricate the implant based on the mirror image of the contralateral side.

Image 5-3. Test the appropriateness of the 3D printed model using 3D imaging of the implant.

Image 5-4. The 3D printed implant is fitted into the model of the patient’s bone structure.

If the implant is the right fit with the patient’s bone structure, we now have to make additional corrections to the design to accommodate the position of screws and the force of contraction on the mandible. However, we had to stop here as 3D printed implants are not authorized for medical use in the jaws in Korea.

On the other hand, several companies specialize in producing 3D printed implants for similar cases of bone defect in other countries. And surgery using such implants is being performed. A computer software analyzes the force of contraction and relaxation applied onto the implant and calculates the position and number of fixtures for withstanding the calculated pressure. The pre-operation phase is evolving from relying on the doctor’s hunch and experience toward a more scientifically accurate, objective and precise analysis. However, such innovative technology cannot be fully used in clinical practice due to lack of safety data and legal authorization in Korea. I have discussed this matter with many officials in the health authorities, however, failed to see any changes. I have lastly requested for an emergency limited authorization to the Health Insurance Review & Assessment Service of Korea and am awaiting their response.

Image 6. The current state of bone defect in the patient who is not able to receive reconstructive surgery due to regulatory hurdles.

It has been a year since we first planned the reconstructive surgery for this patient and she has lost yet another tooth and the resorption of the remaining bone is continuing. Her pain continues not because of technological limitations but lack of authorization. I sincerely hope that she is able to restore the normal facial structure in the near future.